Loading clinical trials...

Study of Safety and Performance of a Novel Ocular Lubricant in Subjects With Dry Eye Disease | Clinical Trials | Clareo Health

COMPLETEDNA

Study of Safety and Performance of a Novel Ocular Lubricant in Subjects With Dry Eye Disease

A Single-Arm Study to Evaluate and Demonstrate Safety and Performance of a Novel Ocular Lubricant in Adult Subjects With Dry Eye Disease

NCT06444516•Alcon Research

View on ClinicalTrials.gov

Summary

The purpose of this study is to evaluate and demonstrate the efficacy and safety of an investigational ocular lubricant formulation in patients with mild to moderate dry eye disease (DED).

Detailed Description

The study will consist of a Screening visit, a Baseline visit on Day 1, a remote Compliance Check on Day 14, and an Exit visit on Day 30. The expected study duration of participation for each subject is 37 days, with 30 ± 5 days of exposure to the investigational product.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Willing and able to understand and sign an approved informed consent form.
•Exhibit symptoms of dry eye at the Screening visit.
•Best Corrected Visual Acuity equal to or better than 20/80 Snellen in each eye at the Screening visit.
•Willing to discontinue use of all artificial tear supplements and use only the study product as directed starting at Visit 2/Day 1.

Exclusion Criteria

•Pregnant, breastfeeding, or planning to become pregnant during the study.
•Ocular abnormalities that could adversely affect the safety or efficacy outcome.
•Uncontrolled active systemic diseases.
•Use of systemic medications known to cause dry eye.

Locations (9)

Kindred Optics at Maitland Vision Center

Maitland, Florida, United States

Vision Health Institute

Orlando, Florida, United States

Franklin Park Eye Center, PC

Franklin Park, Illinois, United States

Kannarr Eye Care, LLC

Pittsburg, Kansas, United States

SUNY College of Optometry Clinical Vision Research Center

New York, New York, United States

ProCare Vision Center

Granville, Ohio, United States

Wyomissing Optometric Center

Wyomissing, Pennsylvania, United States

Optometry Group, PLLC

Memphis, Tennessee, United States

Clarke Eyecare Center

Wichita Falls, Texas, United States

Key Dates

Start Date

September 4, 2024

Primary Completion Date

February 7, 2025

Completion Date

February 7, 2025

Last Updated

February 18, 2026

Enrollment

188

ACTUAL participants

Conditions

Dry Eye Disease

Interventions

FID123300 ocular lubricant

OTHER

A Non-interventional Study to Evaluate the Anti-inflammatory Effects and the Clinical Efficacy of Topical Water Free Cyclosporin 0.1% Eye Drops in Patients With Dry Eye Disease and Associated Ocular Surface Inflammation Non-responding to Artificial Tears: the FOCUS Study

NCT07463950

Dry Eye Disease (DED)

View study

RECRUITING

A Study on the Correlation Between Tear Iron Levels and the Severity of Dry Eye Disease.

NCT07363824

Dry Eye DiseaseIron

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 18, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Study of Safety and Performance of a Novel Ocular Lubricant in Subjects With Dry Eye Disease

Inclusion Criteria

Exclusion Criteria

A Non-interventional Study to Evaluate the Anti-inflammatory Effects and the Clinical Efficacy of Topical Water Free Cyclosporin 0.1% Eye Drops in Patients With Dry Eye Disease and Associated Ocular Surface Inflammation Non-responding to Artificial Tears: the FOCUS Study

A Study on the Correlation Between Tear Iron Levels and the Severity of Dry Eye Disease.

Supplementary Kelulut Honey Therapy in Juvenile Open-Angle Glaucoma: Effects on IL-6, RNFL and Dry Eye

Role of Corneal Nerves in Dry Eye Disease

Moderate-to-Severe Dry Eye Disease Relief Using Acoltremon

Clinical Study Evaluating Nordlys™ SWT IPL for Dry Eye Disease (DED) Due to MGD